HOME | PGR SINALEVI | POWER | HACIENDA | IDH COURT | LEGAL DICTIONARY | HELP | SITE MAP JUDICIAL PJ Search: Regulations >> Law 9234 >> Date 04/22/2014 >> Full text Internet Search Articles << Articles >> Standard Sheet Regulations Remember that Control F is an option that allows you to search the entire text Pronouncements Constitutional Affairs Go to the end of the document Year: 50 results - You are in the latest version of the standard- Search in: Document file Search Biomedical Research Regulatory Law No. 9234 Advanced Search Menu THE LEGISLATIVE ASSEMBLY Text complete Standard sheet OF THE REPUBLIC OF COSTA RICA Regulations affected Concordances DECREE: Regulations Descriptors text-align: center '> REGULATORY LAW OF BIOMEDICAL RESEARCH PGR pronouncements Constitutional actions and resolutions Related case law CHAPTER I Jurisp of the Treasury GENERAL DISPOSITION Options: ARTICLE 1.- Object of the law save The purpose of this law is to regulate biomedical research with human beings in Print health matters, in the public and private sectors. Article sheet ARTICLE 2.- Definitions For the purposes of this law, the following definitions are established: Autonomy: ability of people to make decisions without the influence of other people or external pressures. Adverse event or reaction that would be attributable to experimentation: occurrence unfavorable that: a) results in death, b) life threatening, c) requires hospitalization of the participant or prolongation of the existing hospitalization, d) produces persistent or significant disability or disability, or produces a congenital anomaly or birth defect. Multicenter study: clinical study conducted according to a single protocol in more than a place and, therefore, made by more than one researcher. Phases of vaccine development: Phase I: refers to the first introduction of a vaccine under trial in a human population to initially determine its safety and its biological effects, including its immunogenicity. Is Phase may include dose studies and routes of administration. Phase II: refers to the initial trials to determine the effectiveness of the vaccine in a limited number of volunteers; This phase focuses on immunogenicity. Phase III: aims to more fully assess the safety and effectiveness in the disease prevention, involving a greater number of volunteers in a study generally multicentre properly controlled. Phases of drug development: Phase I: consists of the introduction of a drug in humans for the first time. Healthy voluntary subjects participate to assess at what levels of drug use observed toxicity. Dose-response studies are continued in patients to determine the medication safety and, in some cases, initial indications of its effectiveness. These studies are intended to establish a preliminary assessment of safety and profile. pharmacokinetic and, when possible, a pharmacodynamic profile. Except duly exceptions based, they are carried out in small groups of healthy volunteer individuals. To this phase the bioequivalence studies also belong, since these are also carried out in Healthy volunteers Phase II: consists of controlled clinical trials, designed to demonstrate effectiveness and relative security It is usually done in a limited number of patients closely supervised Phase III: it is done after establishing a reasonable probability of the effectiveness of the medication and aims to obtain additional information on its effectiveness for indications speci fi c and a more precise definition of the adverse effects associated with the medication. This phase It includes controlled and uncontrolled studies. Phase IV: trials are carried out after the national drug registration agency has approved a medication for distribution or marketing. These trials may include research aimed at exploring a specific pharmacological effect, establishing the frequency of adverse reactions or determine the effects of long-term administration of a medication. Intervention: all actions of any order, related to the investigation with beings humans, which may affect in whole or in part, individually or collectively, in one way or another, the dignity and identity, integrity and well-being of people or any of their rights Human and fundamental freedoms. This type of research differs from studies. observational in which there is no intervention. Biomedical research: a type of activity designed to develop or contribute to generalizable knowledge about health in human beings. It can be observational, epidemiological, or non-interventional or experimental, clinical or interventional. For the purposes of this law, any reference to research will be understood as biomedical research with human beings in health matter. Observational, epidemiological or non-interventional biomedical research: research in which no diagnostic or therapeutic intervention is performed for experimental purposes, nor subject the participating individuals to conditions controlled by the researcher. For the purposes of This law, any reference to observational research will be understood as biomedical research observational, epidemiological or non-interventional in humans in terms of health. Experimental, clinical or interventional biomedical research: any investigation scientist in the area of ​​health in which a preventive, diagnostic or therapeutic to humans, in order to discover or verify the clinical, pharmacological or pharmacodynamics of an experimental product, a medical device or a clinical procedure or surgical; or that attempts to identify any adverse reaction of a product, device or experimental procedure; or study the absorption, distribution, metabolism and excretion of a experimental product, in order to assess its safety and effectiveness or assess the outcome before a unproven psychological intervention. For the purposes of this law, any reference to clinical research It will be understood as experimental, clinical or interventional biomedical research in humans in health matters. Researcher: person who exercises a profession recognized in the Costa Rican State, accredited by the Conis to carry out biomedical research, given its scientific training. The Researcher is responsible for conducting the investigation. If it is a team that performs the study in a center, the investigator responsible for the team will be called principal investigator. Contract management organization: person or organization that signs a private contract with the sponsor, the contract research organization (ICO) and / or the researcher, to perform one or more of the tasks and functions of the researcher in the execution of the study. Must be accredited by Conis. Contract research organization: person or organization that signs a contract private with the sponsor, to perform one or more of the work and functions of the sponsor related to the study. Must be accredited by Conis. Participant: individual who participates in a biomedical research project, either as direct receiver of an intervention, as a control, or as an element of observation. The individual it can be a healthy person who voluntarily participates in the investigation, or a person with a condition unrelated to the ongoing research that participates voluntarily, or a person, usually a patient, whose condition is relevant to the use of the product studied or to answer the questions that are being investigated. Sponsor: individual, company, entity or public or private organization, national or foreigner, who takes responsibility for startup, administration, financing and publication of the results of an investigation, and which also assumes the coverage of costs and compensation. Placebo: substance that itself lacks therapeutic action. Impartial witness: a person independent of biomedical research that cannot be in fl uenced by personnel involved in biomedical research (understood as such the sponsor, the contract management organization, the contract research organization, the investigator or officials, employees or representatives of both), or a family member of the participant, who is present in the process of signing the informed consent. Protocol: document that describes the hypothesis, the objective or the objectives, the design, the methodology, statistical considerations and organization of a study. Also, provides the background, the basics and the justification of the study. Article sheet ARTICLE 3.- Protection of the human being The life, health, interest, well-being and dignity of the participants in an investigation in health, in which human beings participate, will prevail over the interest of science, of interests Economic or commercial. All health research involving human beings must respond to an approach of human rights. Article sheet ARTICLE 4.- Principles of biomedical research All health research involving human beings must be governed by the principles of respect for people's dignity, bene fi ciency, non-maleficence, autonomy and justice Distributive In addition to the above, the respective scientific ethical committee must ensure that it complies with the requirements of social and scientific value, scientific validity, non-discriminatory and equitable selection of Participating populations, favorable risk-benefit ratio, independent evaluation, consent Human rights as a frame of reference. Article sheet ARTICLE 5.- Gratuity Participation in a biomedical research should always be voluntary, so you do not will reward the participants. Only expenses incurred by an event may be reimbursed. subject for their participation in the investigation. In the case of bioequivalence studies, in addition to the recognition of expenses, it will be allowed the remuneration to the participant for their voluntary participation. Said remuneration must be previously approved by the CEC, making sure that these payments are proportional to the study design. The scientific ethical committee that evaluates the research must establish and execute special protection measures for the participant during recruitment and development, to protect the principle of autonomy. Article sheet ARTICLE 6.- Obligations of the State It is the obligation of the State, in terms of research with human beings: a) Guarantee the rights and security of the participants involved in the activity researcher b) Ensure compliance with ethical standards that guide research in beings humans. c) Establish strict mechanisms for regulation, control and monitoring of research biomedical, to ensure the protection of the participants and the correct preparation of the investigations. d) Guarantee the right to research in higher education institutions. e) Promote scientific and technical research aimed at solving the needs and health problems of the Costa Rican population. f) Promote scientific and technical research in all the structures of the National System of Health and higher education institutions. g) Promote the training of the personnel of the National Health System in the theoretical principles, Practical and ethical-legal research. h) Promote and encourage the execution of clinical studies, bioequivalence and others contemplated in this law, by the national pharmaceutical industry, in coordination with the institutions public and when these are aimed at solving the health needs and problems of the Costa Rican population Article sheet ARTICLE 7.- Public health research Public health research, observational, will require the approval of the Ethics Committee Scientist, hereinafter CEC, except in the case of investigations of the institutional work of the Ministry of Health or the Costa Rican Social Security Fund and referred to investigations related to: a) Prevention and control of endemic and epidemic diseases that require collection of relevant data for health decisions, such as outbreaks or epidemics. b) Public health surveillance, which incorporates data collection in ballots or files electronic that must be sent to the Ministry of Health to define, based on its analysis epidemiological, prevention and control actions. c) Evaluation of social programs or evaluation of results and impact of interventions in public health. d) Pharmacovigilance intensive medication and vaccines, so that they can be taken actions related to security, warnings or commercialization of these. Investigations of the institutional work will be considered those that the institution must necessarily perform to fulfill the functions assigned to it and that are found within your operational plan, or in case of emergency. Institutions that carry out this type of research must provide a report of the Final results of the study to Conis. Article sheet ARTICLE 8.- Competence of the Ministry of Health The Ministry of Health, in order to comply with the scope of this law, shall define the policies public for the development of biomedical research. Article sheet CHAPTER II INFORMED CONSENT ARTICLE 9.- Informed consent The participation of an individual in an investigation regulated by this law will require the express, specific, written and signed consent or with the fingerprint of this or its legal representative, on all sheets. Informed consent is the process by which a person confirms, voluntarily, your desire to participate in a biomedical research. The objective of informed consent is to protect the participants, so they cannot become a mechanism to legally protect the researcher, the sponsor, the organization contract management and contract research organization. Article sheet ARTICLE 10.- Minimum content of the informed consent document The information in the informed consent document must be truthful, clear, accurate and written in a way that can be understood by the participants and that does not lead to error or coercion. It must contain at least: a) Statement that the study involves research. b) Identity of the professional responsible for the research and its collaborators. c) Explanation of the objective and purpose of the investigation. d) Source of funding for the research project. e) Approximate number and characteristics of the people who will participate. f) Expected duration of the person's participation. g) Procedures to be followed. h) In case of obtaining blood samples and other biological material, there must be consent and the right to retract the participant on the transfer of samples biological material, the tests that will be performed, where they will be analyzed and if will deliver or not the results of these. In case you want to save them you must indicate where, for how long and for what purposes. i) Description of the risks or inconveniences that may arise with the investigation. j) Measures to respond to any inconvenience or adverse events that may arise. k) Measures to ensure adequate compensation in case the participant suffers Some damage as a result of the investigation. l) Description of the expected benefits for the participant or for others. m) Demonstration of the strict confidentiality of the information and the measures to be taken to ensure it. n) Information on the people who will have access to the records to verify Procedures and research data. ñ) Measures to access the relevant information for the participant, arising from the research or the total results of this. o) Measures to maintain the confidentiality of the results of the investigation, as well as the information of the participants at the time of the dissemination of the results. p) Indicate any potential future use of the research results. q) Indicate that, in the publications of the research results, the information of the person will remain confidential. r) Statement that participation is voluntary and that the person may withdraw from the research at any time without losing the bene fi ts to which the person of all Forms you have the right, nor to be punished in any way for your withdrawal. s) Clarification of whether there will be any kind of financial compensation for food or transportation t) List of people who can contact if you have questions about the study and Your rights. The list must contain at least the telephone number (s), the address of email, the address of the office and any other suitable data to locate them. u) The name, signature, date, time and place where the participant is summoned to deliver the copy of the document and the place where you subscribe and the identification number of the participant or his legal representative, of the person who explains the informed consent and of the impartial witness who signs the consent and the date on which it is signed. v) The others determined by the regulations of this law and those others that in the opinion of the committees Ethical respective scientists are required. Article sheet ARTICLE 11.- Additional content of informed consent in investigations clinics In clinical research, in addition to what is indicated in the previous article, consent informed must contain: a) Treatment to be used in the investigation, the form and probability of assignment to each treatment b) Known side effects, risks and discomforts of medications or equipment in investigation. c) Alternative, preventive, diagnostic and therapeutic procedures or treatments available. d) Precautions with men and women of reproductive age and follow-up that will be given to the woman and the product, if she had become pregnant during participation in the investigation. e) If the treatment will continue at the end of the study. f) Regarding the insurance policy. g) The others determined by the regulations of this law. Article sheet ARTICLE 12.- Approval of informed consent Informed consent and any modification thereto must be approved, foliated and sealed in all its pages by the Scientific Ethical Committee, prior to its presentation to the eventual participants. In the cases of observational investigations, the Scientific Ethical Committee, after analysis exhaustive of the content and scope of the investigation, may exempt from the signature of consent informed, when it considers that this does not affect the rights of the participants. Article sheet ARTICLE 13.- Quality of the information Before any activity related to the investigation is initiated and before it is initiated proceed to sign the informed consent, the participating individual must be informed in his own language, in an appropriate and understandable language, about the nature of research, the procedures, risks and bene fi ts, other therapeutic or diagnostic options, confidentiality of the information collected and about your rights, so that you understand and make the decision to participate or not, freely, voluntarily and consciously, without coercion, coercion, threat, fraud, deception, manipulation or any other type of pressure. The informed consent information must be truthful, clear, accurate and written, so that does not lead to error, deceit or coercion and that can be understood by the participants. For this one In effect, it must be ensured that the procedure for signing informed consent counts with the appropriate time and conditions so that people can understand correctly information. Article sheet ARTICLE 14.- Information of the informed consent The use of information and data relating to people's health is prohibited, with purposes not contemplated or allowed in the informed consent or in the law. The person in charge of the research or clinical trials and those responsible for it may only use the information and data related to the health of the participants in accordance with Article sheet ARTICLE 15.- Modification of conditions Any modification in the risk-benefit ratio or in the conditions that arise During the investigation, the participant must be informed, so that he or she is by granting a new consent or an addendum to the principal, ratify your stay in the study or trial, or decide to withdraw from it. Article sheet ARTICLE 16.- Informed consent in persons with disabilities When people with disabilities participate in a biomedical research, the information required to provide informed consent must be given in accessible conditions and formats and appropriate to your needs. Article sheet ARTICLE 17.- Consent of minors When minors participate in a biomedical research, the consent Informed must be signed by your legal representative or by whoever has your legal representation. In the case of minors, but over twelve years old, you must also count on your informed consent; To do this, they will be informed about the scope of the research, in a language understandable to them. In the event that the minor refuses to agree, his or her criteria prevails over that of your legal representative, as long as your life or your health does not depend on your participation in the research, in accordance with the provisions of Law No. 7739, Childhood and Adolescence Code, of January 6, 1998. All aspects related to informed consent in minors must be valued with the participation of the Scientific Ethical Committee, so that the Committee is guarantor of this. The informed assent must be approved, folded and sealed in all its pages by the CEC, prior to submission to potential participants. Article sheet ARTICLE 18.- Consent of legally disabled persons In the case of biomedical research involving people declared as unable, through a judicial process, informed consent must be signed by your legal representative. Article sheet CHAPTER III BIOLOGICAL SAMPLES OF HUMAN MATERIAL ARTICLE 19.- Use and transfer of biological samples The use of biological samples obtained for purposes not covered and prohibited is prohibited. approved in the informed consent, the law and other applicable regulations. Biological samples may only be transferred abroad, if justified in accordance with the scientific objectives, the technical criteria of the research or the technological limitations of the country. In the case of studies with multicenter design, where it is optimal to standardize the methodology and laboratory test reports, in accordance with the scientific objectives, are It will allow the transfer of samples to a laboratory abroad. In order for biological samples to leave the country, it is required that such information be supplied prior to export, in informed consent and that the participant has consented, except epidemiological situations that put public health at risk. Article sheet ARTICLE 20.- Right to retract for the use of biological samples of material human The participant in a biomedical research assists the right to retract their consent on the possible transfer, storage, handling and use of your biological samples of human material Article sheet ARTICLE 21.- Transfer agreements To transfer any biological sample outside the country, you must have an agreement to transfer of biological material, signed by the legal authorities of the institutions involved, by the researcher and the sending institution, and by the researcher and the institution that receives. Article sheet ARTICLE 22.- Conservation and destruction of biological samples of material human Biological samples of human material will be preserved only as long as they are necessary for the purposes that justified their collection, unless the participant has granted their explicit consent for other later uses. This consent may be revoked by the participant totally or for certain purposes, at any time. When the revocation is referring to any use of the sample, it will proceed to the immediate destruction of this and the laboratory extend a written certificate of the destruction of the sample, except in the case of samples that have been anonymized In case the biological samples of human material are preserved, the participant will be informed of the place and of the conservation conditions, objectives, future uses, assignment to third parties and conditions to request their destruction, according to the rules that apply to the destruction of biological samples, except in the case of samples that have been anonymized. Article sheet ARTICLE 23.- Donation or transfer of biological samples of human material To donate or transfer a biological sample of human material to third parties, you must have specific informed consent for any of those purposes. In this, the place and conditions of conservation, the objectives of this conservation, the future uses of samples and the possibility of transfer of the samples to third parties. The donation and use of human biological samples in an investigation may not Remuneration or other compensation to the participant; it is also prohibited the sale of biological samples that have been obtained for a biomedical investigation. Article sheet CHAPTER IV RIGHTS AND OBLIGATIONS OF PARTICIPANTS ARTICLE 24.- Right to withdraw Participants in an investigation will have, without the need to give explanations, the right to Give up your participation at any time. In those cases in which the abrupt withdrawal means a risk to the health of the participant, the mechanisms that Minimize the risk situation. Such resignation will not cause any damage or inconvenience to the participants, for your right to health or in the exercise of any other of your rights. Article sheet ARTICLE 25.- Right to confidentiality The use of data related to the health of persons for purposes other than those for whom consent was given. Participants in an investigation will have the right to be saved confidentiality about your identity, personal information and your health, as well as about the treatments or the results of the analyzes or procedures to which they were submitted and other personal data, except when the law requires otherwise. People or entities that have access to confidential data of the participants must take all necessary measures to ensure that privacy will not be affected, the confidentiality, integrity and dignity of the participants. To this end, anyone who in the exercise of their functions, in an investigation where human beings participate, have access to personal data or confidential documents related to the investigation, will be subject to duty of confidentiality. The obligation of confidentiality does not apply when any of the following conditions exist, which must be consigned and accepted by the participant in the consent informed: a) When required by the scientific ethical committee that approved the research. b) When required by the National Health Research Council, in order to comply with the requirements of an inspection and surveillance of an investigation. c) When the monitor or the auditor of the investigation requires verifying the data contained in the clinical records of the participants of an investigation, for purposes of an audit or follow-up by the sponsor or competent regulatory authority. d) When requested by a competent judicial authority. e) When a medical emergency occurs to the participant. f) When the doctor responsible for clinical care requires to know such information to Treatment effects of your patient. Article sheet ARTICLE 26.- Transfer of data The transfer of personal data to third parties outside an investigation where they participate Human beings will require the express and written consent of the participant. If the data obtained from the participant could reveal personal information of their family members, the transfer to third parties will require the express and written consent of all interested parties. Article sheet ARTICLE 27.- Right to information Participants in an investigation are entitled: a) To access, personally or through their legal representative, the results of their analysis, when these have not been subjected to dissociation or anonymization processes, if the Study design allows. b) To be informed about the advances, of the unexpected adverse events that occur present and of the general results of the investigation. c) That the ethnic, cultural and social characteristics of the community or group are respected population to which they belong. d) That all verbal and written information be provided through an understandable lexicon and in The language of the participants. e) To be informed of discovered diseases that are not part of the process of investigation. f) To access and obtain a copy of your personal file, which must include all the information regarding the research or clinical trial. Article sheet ARTICLE 28.- Right to enjoy the benefits that result from the investigation Participants in a clinical investigation will have the right to enjoy for free, they require it, of the preventive, therapeutic and diagnostic treatments generated by the study, if it has been shown that these are beneficial to health, as long as the prescription of these methods or treatments are endorsed by the professionals responsible for the treatment and monitoring of the patient, and in accordance with what is expressed in this law. Article sheet ARTICLE 29.- Right to health care No participant in a biomedical research will lose their right to receive care in health that you would be entitled to receive before, during or after your participation in an investigation. Article sheet ARTICLE 30.- Right to compensation for damages People who have suffered damage to health, as a result of their participation in a investigation, they will receive the corresponding compensation as provided in this law and their regulation. Article sheet ARTICLE 31.- Protection policy for the participants The clinical investigation must be covered by a civil liability policy that protects the participants of the damages and losses derived from the investigation, during the period that lasts, since the beginning of the investigation and for at least two years, after the end of the Participation of the participant in the investigation. Policies must be issued in coherence with the principle of proportionality and dignity of human life, and must be enforceable in the country. The ethical scientific committees must assess the policy that is presented and define its term of validity starting from the minimum established in this law. The Ministry of Health will regulate the process that guarantees the access of the participants to the benefits offered by the assurance of health research. Article sheet ARTICLE 32.- Information to people who participate in biomedical research In the informed consent given to the potential participant, it must be delivered proof or copy of the policy, indicating the number, the issuing entity, the term of protection, the conditions that the policy will have and the procedure to access it by the Participants Article sheet ARTICLE 33.- Obligations of the persons participating in a biomedical investigation They will be obligations of the people participating in research in which beings participate human the following: a) Comply with the instructions and instructions provided. b) Timely inform the investigator about the adverse events they present. c) Inform the attending physician of their participation in a clinical investigation. d) The others determined by the regulations of this law. Article sheet CHAPTER V NATIONAL HEALTH RESEARCH COUNCIL ARTICLE 34.- National Health Research Council The National Health Research Council, hereinafter Conis, is created as an organ independent, multidisciplinary, ethical, technical and scientific, attached to the Ministry of Health with a degree of maximum deconcentration and with instrumental legal personality. The Conis will have the administrative structure defined by regulation and will have its own Internal audit in accordance with Law No. 8292, General Internal Control Law, of July 31, 2002, and Law No. 7428, Organic Law of the Comptroller General of the Republic, of September 7, 1994 Article sheet ARTICLE 35.- Conis Purposes The purpose of the Conis will be to guarantee the quality of the investigations and their strict adherence to the human rights. Its members must act with absolute independence of opinion, avoiding in its decisions the influence of political and commercial interests. Article sheet ARTICLE 36.- Formation of the National Health Research Council The Conis will consist of seven proprietary members, each with their respective alternate, who must attend the sessions in the absence of the owner member. The Conis will be integrated by: a) The Minister of Health or the official in whom this delegate and his alternate, who will preside. b) The Minister of Science and Technology or the official in whom this delegate and his substitute. In in case the minister or the minister delegates his representation, both the holder and the substitute They must be research specialists. Otherwise, at least the substitute must be Specialist in this field. c) A human rights lawyer and his deputy, appointed by the College of Costa Rican lawyers. d) A representative of the Costa Rican Social Security Fund (CCSS), preferably from the Center for Strategic Development and Information on Health and Social Security of Social Security (Cendeisss) and his alternate. The Board of Directors may not designate any of the persons who at that time be part of its members. e) A representative of the National Council of Rectors (Conare) and a substitute, who must be bioethics specialist. f) A representative in property and a substitute, member of the Professional Associations of Physicians and surgeons; Pharmacists; Dental and Microbiologist Surgeons, appointed by the boards of the respective professional associations. The regulation of this law will establish the appointment procedure and how they will alternate each year, the charges in ownership and substitution between the four professional colleges, so that the posts. g) A proprietary member and a substitute representing the community, which for that purpose will be appointed by the Ombudsman's Office. The procedure for choosing the representative of the community will be determined by the Ombudsman's Office. The members of the Conis will last in their positions a period of five years and may be re-elected The community representative will be appointed for a maximum period of three years and not may be re-elected The members of the Conis may be dismissed from their positions for the reasons they indicate in the regulation of this law. The members of the Conis may not be named simultaneously in the Conis or in any other scientific ethical committee (CEC). Article sheet ARTICLE 37.- Diets The members of the Conis will be remunerated by per diets per session, whose amount will be to eighty percent (80%) of the allowances paid to the members of the Board of Directors of the Fund Costa Rican Social Security for each session. The number of sessions paid monthly may not exceed ten sessions per month, between ordinary and extraordinary sessions. The Conis will ordinarily meet once a week and, extraordinarily, whenever necessary, by call made by its president or by not less than two of its members. No member of the Conis may directly or indirectly receive remuneration or recognition any material from sponsors, researchers, management organizations by contract or contract research organizations. The members of the Conis that incur in this fault will be dismissed from their charges. Article sheet ARTICLE 38.- Academic and professional requirements to integrate the Conis The members of the Conis, holders and substitutes must be professionals in the fields of human rights, bioethics, clinical research, epidemiology, public health or health services. To occupy a position in the Conis requires at least: a) Possess a university degree with a minimum degree and be attached to the respective school. b) Have recognized and proven honorability. These requirements do not apply to subsection g), as well as in the case of whoever holds the position of minister, indicated in article 36 of this law. Article sheet ARTICLE 39.- Revocation of appointment The National Health Research Council, by simple agreement, may request the organ or the corresponding institution that the appointment of any of its members be revoked by unexcused absences, breach of their functions within the Conis or due to conflict of interest Article sheet ARTICLE 40.- Ad hoc members and special commissions The Conis may incorporate, temporarily and to the extent deemed necessary, consultants or experts, who will not have the right to vote. It may also form subcommissions or working groups for the technical analysis of specific projects or topics. The people that make up the National Health Research Council may not be part of, simultaneously, any other scientific ethical committee of the country. The Conis is authorized to cancel against the institutional budget for consultants or experts that require hiring to meet the objectives of this law Article sheet ARTICLE 41.- Confidentiality agreement and declaration of conflict of interest The members of the Conis and all the personnel must sign, before beginning work, an agreement of con fi dentially, make a declaration of activities and conflict of interest, and must refrain from taking part in deliberations and voting in which they have a direct interest, indirect or familiar in the matter examined; for this, they must reveal any conflict of interest that It can affect your objectivity. Article sheet ARTICLE 42.- Quorum The quorum will be integrated with the presence of the majority of the members. The agreements will be taken with the concurrent vote of the majority of those present. When there is a tie, the president Will resolve with your vote of quality. The resignation or termination of one of the members shall not imply disintegration of the organ, as long as the quorum required to meet remains. Article sheet ARTICLE 43.- Functions of the Conis They will be functions of the Conis: a) Regulate and supervise and monitor biomedical research and guarantee life, health, interest, well-being and dignity of people. b) Accredit, register and supervise the operation of CECs, both public and private, a contract management organizations (OAC) and research organizations by contract (ICO). c) Accredit researchers who carry out biomedical research. d) Resolve, within a period not exceeding three months, the conflicts between researchers and the CEC. e) Know and timely resolve complaints or claims against investigators, ICO, OACs, CECs or the entities on which they depend. f) Supervise and inspect any OAC, OIC, CEC, researcher or research project to verify compliance with established standards. g) Suspend, for reasons of proven urgency, or cancel at any time, the approval of a research project, if it is determined that freedom is endangered, the dignity, privacy, health or welfare of the participants. h) Suspend, temporarily or permanently, the accreditation of a CEC or researcher, if determines that it is not complying with the provisions of this law. i) Promote and promote training in research bioethics, at the national level in general, and in particular to CECs, to sponsors and researchers. j) Inform, in writing, the health authorities of the health regions of the Ministry of Health, about the investigations approved and that are to be carried out in your jurisdiction. k) Manage the budget allocated in this law. l) Present an annual report of functions to the institutions represented in the Conis. m) Verify that CECs have adequate and sufficient financial resources for their functioning. The Conis may require the entities that constitute the CEC that provide them with adequate and sufficient human and material resources for its proper functioning. n) Keep a national registry of all biomedical research carried out in the private and public centers in the country verifying that the CEC must send at the time of Approve an investigation and before it begins, which will be publicly accessible. ñ) Keep a national registry of the health entities or establishments that you carry out biomedical research o) Establish a national registry of researchers. p) Keep a national registry of research and administration organizations by contract. q) Keep an updated record of the CECs and of the researchers, sponsors, OAC and ICO that have been sanctioned for breach of this law. r) Keep a record of publications and presentations in scientific activities of the Results of biomedical research approved in the country. s) Define, annually, the work plans and budgets necessary to exercise their functions. t) Ensure compliance with the ethical standards that guide biomedical research. Implement a biomedical research information system, accessible at all times, with updated databases on approved and rejected investigations, Registered researchers, CEC, OIC and OAC, information and guidance for potentials Research participants. u) Keep a national registry of the investigations that have been rejected and the reasons that They substantiated the decision. v) Keep a duly legalized record containing all your meetings and Conis agreements. w) Keep a record of the sanctioned investigators and the reasons that motivated the sanction. x) The others that the regulation of this law establishes. Article sheet ARTICLE 44.- Inspection The Conis will have inspection powers to the CEC, OAC, OIC, investigators or investigations Biomedical, when deemed necessary. For this purpose, the Conis will have the following functions: a) Carry out inspections in any field, with the purpose of verifying compliance with requirements established in this law. b) Advise ex officio or at the request of a party, in matters of its competence, to the CEC, OAC, ICO and researchers. c) Evacuate consultations regarding the competence of the CEC, OAC, ICO and researchers. d) Notify the parties involved of the findings in the inspections carried out. e) Initiate the corresponding administrative and judicial procedures in case of determining any breach of this law, within the deadlines established by regulation. f) The other functions assigned to it by regulation. The subjects referred to in this article must provide the information required by the Conis in the term that this determines, under penalty of incurring the sanctions established in this law. The Conis must hire and train the necessary personnel to fulfill the functions that Grant this item. Article sheet ARTICLE 45.- Budget The budget of the Conis will consist of the following resources: a) The amount of income from registration and registration of investigations. b) Legacies, grants and donations from public institutions or organizations and State contributions. c) The generated by its financial resources. d) The income received from accreditation, certi fi cations, registrations by educational activities and, in general, for the provision of the services it provides. e) The amount of fines generated by the application of this law. The Conis will be subject to compliance with the principles and the Responsibility Regime established in titles X and XI of Law No. 8131, Financial Administration of the Republic and Public Budgets, of September 18, 2001. In the rest, the Conis of the scope and application of that law. In the fiscalization, the Conis will be subject only to the provisions of the Comptroller General of the Republic. Article sheet CHAPTER VI SCIENTIFIC ETHICAL COMMITTEES ARTICLE 46.- Scientific Ethical Committees Any public or private entity in whose facilities biomedical research is carried out may constitute a scientific ethical committee, hereinafter CEC, regardless of criteria, trained in bioethics of the research and that must be duly accredited by the Conis. The Ministry of Health will form a CEC that will be in charge of the approval of the tests Phase I clinical, as well as research approval of researchers and / or entities independent, public or private, that do not have a CEC. Those independent investigators and / or public or private entities that do not have a CEC, They may also submit the research project to any CEC duly accredited by the Conis. Public or private entities that create a CEC are required to assure you sufficient independence of criteria and operation, as well as all resources for compliance of your obligations. Article sheet ARTICLE 47.- Integration The CEC must be multidisciplinary in its composition and its members must have recognized honorability, at least one scientific expert with research experience and a person representing the interests of the community, appointed through mechanisms that seek the widest possible consultation and participation, in accordance with the respective regulations. They must have a minimum of five members and will be governed by the rules established in this law and its internal regulations. Both CEC members and support staff must sign an agreement to Confidentiality and declaration of conflict of interest. Article sheet ARTICLE 48.- Functions and obligations of the scientific ethical committees (CEC) The functions and obligations of the CEC are: a) Ensure that biomedical research strictly respects life, health, and interest, well-being and human dignity and rigorous requirements and criteria are met scientifically, as well as the ethical norms that regulate the subject, among them, the process of Informed consent, suitability and experience of researchers, and requirements established in this law. b) Protect the rights, security, freedom, dignity and well-being of the subjects that They participate in a biomedical research. c) Take into consideration the principle of justice, so that the benefits and Disadvantages of research are distributed equally among all groups social classes. d) Dictate its internal operating regulations, which must be approved by Conis as accreditation requirement e) Know, approve or reject research projects in which beings participate human, within the deadlines established in its internal regulations. f) Provide information to update the National Registry of Biomedical Research at time to approve an investigation and before it begins. g) Know, approve or reject requests for renewal of research projects biomedical, within the periods established in the regulations of this law. h) Know, approve or reject the amendments to the original protocol, informed consent and to informed assent. i) Suspend or cancel, at any time, the execution of a project of investigation, if it is determined that the health or well-being of the participants. j) Keep a duly legalized book of records in which all your meetings and a file of each of the projects presented to them for review. k) Follow up on the execution of the projects through the reports submitted periodically the principal investigator and perform, at least once a year, an audit to Each institution and research center. You should also know the finalization report of the study. l) Review, record and communicate to the Conis all serious or unexpected adverse events and most relevant situations that occur during the development of the investigation that are reported to the CEC. m) Preserve and guard the archives of the projects submitted to their knowledge and all the documentation that supports your actions for a period of fifteen years after the Completion of each investigation. n) To send quarterly and annual reports of its management before the Conis, which include the investigations approved, rejected, suspended, canceled and finalized, amendments to active investigations, inspections carried out and the list of active investigations. ñ) Offer training to its members, so that they receive regular training and continuing education in relation to bioethics and biomedical research. o) Guarantee researchers the possibility of presenting the objections they consider necessary in relation to the agreements of the CEC. p) To inform the Conis and the competent institutional authorities of the irregularities or breaches of this law. q) Evacuate immediately the inquiries of the participants of an investigation when request information about your rights, and process, as soon as possible, complaints that these present in relation to the investigation or to the proceeding of an investigator or his human team. r) Comply with the provisions of the Ministry of Health and the Conis regarding their competence. s) The amounts to be paid to the CEC for the review process of the research projects submitted for review, possible approval and for the supervision, renewal and inspection of The approved projects will be those determined by the CEC after the cost analysis corresponding and in accordance with the regulations of this law. t) Keep a record of the publications or presentations made of the results of investigations approved by the committee. u) Notify the National Children's Board when they are approved or renewed investigations of minors, for what it may concern. v) The others established by the regulations of this law. Article sheet ARTICLE 49.- Incompatibilities They may not be part of the CEC: a) The members of the boards of directors of public institutions or private companies promoters of biomedical research, when they participate directly or by interposite person of the capital stock of private companies of this nature or their spouse, partner or some of their relatives by consanguinity or affinity until the third grade inclusive. b) The officials of the entity, public or private, in which the committee is established, in which they or their spouse, or partner, or any of their relatives by consanguinity or affinity until the third grade even occupy leadership or management positions that imply competence to decide on the authorization of biomedical research projects. When one of the members of a CEC has links that imply a risk of conflict of interest, in accordance with the provisions of article 38 of Law No. 8422, Law against Corruption and the Illicit Enrichment in the Public Function, of October 6, 2004, and its reforms, and others regulations of the legal system, you must refrain from participating in the administrative process, the approval, control and monitoring of that specific investigation. Article sheet ARTICLE 50.- Budget and resources The entities that constitute a CEC must provide them with human and material resources necessary to fulfill its functions and obligations. Article sheet CHAPTER VII OBLIGATIONS OF THE INVESTIGATOR, SPONSORS, ORGANIZATIONS OF ADMINISTRATION BY CONTRACT AND RESEARCH ORGANIZATIONS BY CONTRACT ARTICLE 51.- Obligations of the researcher The obligations of the researcher responsible for the execution of biomedical research are: a) Strictly respect life, health and human dignity and meet the requirements and criteria of scientific rigor, as well as the ethical norms that regulate the subject and requirements established in this law. b) Stay updated on bioethical aspects and good clinical practices. c) Ensure that the conduct of biomedical research implies, in all cases, that routine care, procedures and treatments that participants require are put before the investigation Development. d) Have academic training, training and experience to take responsibility of the proper conduct of biomedical research. e) Have a sufficient number of qualified personnel and adequate facilities to carry conducted biomedical research f) Ensure that the members that are part of the research team have the qualification and adequate experience for the proposed research within the exercise of your profession, in concordance with the provisions of Law No. 5395, General Health Law, of October 30, 1973. In the case of students carrying out undergraduate, graduate and postgraduate studies, the CEC respective may exempt them from this requirement to the extent that this does not imply a risk to participants. g) Present the investigation protocol before the duly accredited CEC and, before initiating any activity related to the investigation, have the respective approval. h) Be completely familiar with the investigation and consent protocol informed and, in case of clinical trials, with the investigator's brochure and with the medication, research equipment or material. i) Comply with the provisions of the research protocol approved by the CEC. j) Ensure the obtaining of informed consent in a correct and timely manner by of the participant or his legal representative, when the corresponding CEC has not exempted him of said requirement. k) Keep track of medications, equipment or materials in clinical trials. l) Ensure that the reported data of the biomedical research are accurate, legible, are complete and in the required time. m) Ensure that the persons for whom the special risk research journal is excluded from this. n) To send to the respective CEC, for its revision, all the amendments that occur to the protocol before the changes can be implemented, provided that this does not imply a risk for participants. ñ) Send the international security reports to the respective CEC, in case of investigations or multicenter studies. o) Inform the CEC, within a maximum period of twenty-four hours, of all adverse events serious or unexpected problems occurred in the biomedical research under your charge. p) Send reports to the CEC about the progress of the investigation, through reports quarterly and yearly. q) Offer advice to research participants during the entire development of This, about your rights. r) Ensure, through adequate control, that the potential health benefits of Participants outweigh the risks. s) Inform the participants and the CEC immediately, in case of early termination of the investigation, a detailed explanation of this suspension. In case of clinical trials, ensure appropriate treatment and follow-up for each of the participants. t) Keep in a file all the documentation of each investigation, for a period of fifteen years after the conclusion of the investigation. u) Send a copy of the final report and the final results of the investigation, according to the CEC requirements that approved it. v) Make available to participants the information deemed relevant for the health of these. w) Comply with the ethical, scientific and administrative obligations imposed on it by the research sponsor, the CEC, the Conis or any regulatory entity, with the interest of verify the protection of the rights of the participants in the investigation, in accordance with the current legislation. x) Declare any possible conflict of interest before and during the investigation. and) When you designate an organization to conduct an investigation (organization of administration by contract), you must sign a contract in which the obligations and responsibilities assumed by said organization. z) Comply with the provisions of the Ministry of Health, the Conis and the CEC regarding their competition. a) Forward, to the CEC that approved the investigation and to the Conis, a copy of the publications and / or Certification of participation in scientific activities of the research results. Article sheet ARTICLE 52.- Publication of results of biomedical research It is the obligation of the researcher to publish or present, in any congress or scientific activity, the Results of the biomedical research carried out. By publishing the results of Biomedical research, researchers must respect the accuracy of the data and results obtained, and disclose both positive and negative results, include the information corresponding to the sources of research funding and the sponsoring entities, and indicate the institution or health institutions where the research was carried out. Likewise In the publications, respect for the right of confidentiality of the participants. The Conis may dispense with the publication of the results of biomedical research, when it comes to results with few contributions. Article sheet ARTICLE 53.- Obligations of the sponsor The sponsor's obligations are: a) Ensure and document that electronic data systems meet the requirements of integrity, accuracy, reliability and consistency in the proposed execution and that maintain a security system that prevents unauthorized access of data. b) Select appropriately the researcher, his team and the entity in which will conduct the investigation c) Supervise the conduct of investigations and implement a system of quality standards d) Ensure sufficient funding, adequate material resources and equipment to the researcher and to the entity that will carry out the investigation, by signing contracts that contain these conditions. e) Define and obtain an agreement with the investigator to conduct the compliance investigation with good clinical practices, national regulatory requirements and the protocol approved by the CEC. f) Verify that the sponsoring research has been approved by the respective accredited CEC in the country. g) Provide adequate and permanent training on scientific and ethical methodologies of the Research the researcher and his team. h) Verify that the investigator reports to the CEC those cases in which he found Deviations to the approved protocol. i) Cover the costs of the treatment of the participants who suffered an injury such as Research consequence. j) Compensate those participants who suffered injuries or heirs in case of death, as a direct consequence of clinical research and related to the This procedures, as long as these are not inherent risks of the medications and / or standard procedures; To do this, you must have a valid insurance policy that cover from the beginning of the investigation and up to a minimum of two years after the end of the Participation of the participant in the investigation. Guarantee legal coverage and a policy of civil liability in favor of the researcher and his team, in order to deal with possible claims for injuries or damages attributable to clinical research, as long as no it is due to negligence, inaccuracy or violations of the protocol, in which case the responsibility It is up to the researcher. k) Provide the participant, free of charge and after the conclusion of an investigation clinic, the medication, device or procedure that has been the subject of investigation, except what: i. The medication, device or procedure is no longer effective for the participant or not require, which must be established by the attending physician by resolution duly founded, which will become part of the file and will be communicated to the CEC within three business days after issuance. ii. The development of said medication, device or procedure is suspended. iii. The researcher certifies that it is not essential to preserve the participant's health and there are therapeutic alternatives. iv. The patient does not grant the informed consent required for the continuation of the treatment. l) Notify the investigator, the CEC and the Conis about the reasons that justify the suspension of Biomedical research m) Guarantee the researcher, the CEC and the participants that the suspension of an investigation Biomedical will not affect the latter. n) Certify that in biomedical research the products under investigation (including active comparator and placebo if applicable), be manufactured according to the good ones manufacturing practices, storage conditions indicated, packaging prevent contamination or deterioration during transport and storage, coding and labeling in Spanish and comply with the requirements established by regulation. ñ) Ensure timely delivery of the products under investigation, keep records of the shipment, the reception, disposal, return and destruction of these products. o) Document the financial aspects of the investigation in an agreement between the sponsor and the investigator. p) The sponsor may transfer any or all of its tasks and functions related to the research to a contract research organization (ICO), but will maintain the final responsibility for the quality and integrity of the research data. q) Any task and function related to the investigation, which is transferred and assumed by An ICO must be specified in writing. All obligations described here, which are made to the sponsor in this law, they also apply to the ICO as far as it has assumed the tasks and functions of the sponsor. r) Comply with the provisions of the Ministry of Health, the Conis and the CEC regarding their competition. s) Keep in a file all the documentation of each investigation, for a period of Fifteen years after the conclusion of the investigation. t) Send a copy of the final report and the final results of the investigation to the CEC and the Conis, which must publish them in the digital register that will be created for this purpose. u) Make available to participants the information deemed relevant for the health of these. v) Comply with the ethical, scientific and administrative obligations imposed by the CEC, the Conis or by any regulatory entity, with the interest of verifying the protection of dignity and of the rights of the participants in the investigation, in accordance with current legislation and International ethical guidelines for experimental clinical research. w) Declare any possible conflict of interest before and during the conduct of the investigation. x) When you designate an organization to conduct an investigation (organization of contract administration, OAC), must sign a contract that establishes the obligations and responsibilities assumed by said organization. y) Forward, to the CEC that approved the investigation and to the Conis, a copy of the publications and / or Certification of participation in scientific activities of the research results. Article sheet ARTICLE 54.- Obligations of the administration organization by contract and of the contract research organization They will be obligations of the contract management organization (hereinafter OAC) and of the contract research organization (hereinafter ICO), the following: a) Send quarterly and annual reports of its management to the CEC. b) Submit to the CEC, for registration, the agreement document signed with the sponsor of the research or with the researcher, in order to know the tasks and functions that have been transferred. Likewise, you must transfer to the CEC any modification to this agreement, in a maximum period of eight business days. c) All those that the sponsor or researcher has transferred through the contract or contractual document signed between them. d) Respond, jointly and severally with the sponsor or investigator, to possible damages or damages caused by the tasks or functions that have been transferred. Article sheet CHAPTER VIII RESEARCH WITH HUMAN BEINGS ARTICLE 55.- Approvals and authorizations All research, before its start, must have the written approval of a CEC duly accredited and, in case it is to be carried out in a public or private health center, It must also have the authorization of the corresponding authority or authorities. None authority, public or private, may authorize an investigation without the approval of the respective CEC. In the case of investigations that require the importation of medicines, equipment, devices and supplies, related to approved investigations, approvals and authorizations indicated in the previous paragraph will be indispensable requirements for their Import to the researcher. Article sheet ARTICLE 56.- Control and monitoring of investigations In all cases, the conduct of the investigation must conform to the content of the project to which the authorization had been granted. The health authorities shall, at all times, have inspection powers over the research, being able to have access to the individual medical records of the participants of the investigation, for which they must keep, in any case, their confidentiality. The health authorities, the Conis or the CEC can cautiously suspend the Authorized investigation in cases where the requirements established this law or when they have indications that the health, integrity and safety of the participants is in danger, having to protect their rights at all times. These measures will proceed in the initial act of the administrative process and must be dictated as a preliminary act, in order to guarantee the rights and security of the participants, and due process. They must also notify all interested parties, including the authorities of the health center where I was conducting the investigation. Article sheet ARTICLE 57.- Inapplicability of positive silence It will not be applicable to the approval, fiscalization, control and monitoring processes of Biomedical research projects, in any of its modalities, the fi gure of silence positive regulated in article 330 of Law No. 6227, General Law of Public Administration, of 2 May 1978. Article sheet ARTICLE 58.- Contract Any biomedical research that has external sponsorship to the public or private entity, Where such activity is carried out, you must have a contract by which the rights are regulated and the obligations of both the sponsor and the researcher to carry out the investigation. East contract must indicate the agreed payment for conducting the investigation and include a clause through the which the sponsor is responsible for short and long term adverse events, which are product of this. The absence of such clause does not exempt the sponsor from its responsibility. Saying contract must be signed by the sponsor's representative, the principal investigator and the representative of the public or private entity, and must subscribe before the beginning of the investigation. Article sheet ARTICLE 59.- Prohibition to the hierarchs of public and private institutions The hierarchs and officials of public or private institutions are prohibited from authorizing development of biomedical research or with the same purpose, assign resources of any type of entities under your charge, if such investigations do not have the prior approval of a CEC. The respective authorities of the hospitals of the Costa Rican Social Security Fund, where intends to conduct an experimental clinical investigation, may deny the facilitation of resources to which this article refers, if in your opinion the transfer of any kind of resource could affect the patient care and the medical assistance service in charge of that institution. Article sheet ARTICLE 60.- Canon For the purposes of registering a biomedical research project, the principal investigator you must cancel a sum equivalent to three percent (3%) of the total budget of the investigation. For these purposes, the researcher, the sponsor, the OAC or the ICO must present before the CEC a copy of the contract signed with him and it will be the obligation of the CEC to send a copy of this document to the Conis, in accordance with the provisions of this law. This amount must be paid at Conis at the time of requesting the registration of the approved project. The funds corresponding to the fees mentioned in this article will be destined to finance the following activities: a) The proper functioning of the Conis. b) Training of Conis members and their staff in research, regulation and subjects related to the subject. c) Promote interest in biomedical research, either directly or in collaboration with projects or programs organized by the health authorities or the scientific community integrated by the public sector. d) Collaborate and encourage activities to improve the research and dissemination processes of bioethics, and the rights of users of health services and participants in e) Finance projects of interest to public health defined by the Ministry of Health. Article sheet ARTICLE 61.- Exemption The following are exempt from the cancellation of the fee stipulated in the previous article research: a) Those that are classified as of public interest by the Executive Power. b) Those that are considered a health priority by the Ministry of Health. c) Those that are investigations carried out by students of higher education, with the purpose of obtaining an undergraduate, graduate, postgraduate or similar degree. d) Independent researchers without sponsorship, provided their development and results Lack commercial purposes. e) The investigations carried out by the research programs and projects of the State universities. The foregoing shall not apply, under any circumstances, to research sponsored by pharmaceutical transnationals or for profit organizations. Article sheet ARTICLE 62.- Protection of files All information concerning research carried out in human beings must be recorded in the patient's file and be protected for a period of thirty years, in the Health institution or clinic where it was performed. Article sheet ARTICLE 63.- Use of the placebo The possible benefits, risks, costs and effectiveness of all biomedical research should be evaluated by comparison with the best existing proven intervention, except in the following circumstances: a) The use of a placebo is acceptable in studies for which there is no proven intervention or Existing treatment b) When for methodological, scientific and compelling reasons, the use of a placebo is necessary to determine the effectiveness and safety of an intervention that does not imply risk, serious adverse effects or irreversible damage for patients receiving the placebo. Article sheet CHAPTER IX RESEARCH WITH VULNERABLE GROUPS ARTICLE 64.- Minors and persons without volitional and cognitive capacity The clinical investigation in which a person with legal disability participates, is a person less or without volitional and cognitive capacity, declared judicially, can only be carried out when the results are expected to produce real or direct benefits to your health, or when comparable results cannot be obtained in older individuals or capable of granting their consent. When it is foreseeable that clinical research will not produce results in direct benefit for the health of these participants, the research may be authorized in an exceptional way, if the following conditions will concur: a) That the research aims to contribute to the understanding of the disease or to a beneficial outcome for other people of the same age or with the same disease or condition. b) That the investigation entails a minimum risk and burden for the participant. Article sheet ARTICLE 65.- People highly dependent on health care Clinical investigations should be evaluated with special care when carried out with particularly vulnerable human beings, at the discretion of the CEC, because of their high dependence on health care and / or your limited ability to understand the information provided and express freely your willingness to participate, or both circumstances. Biomedical research they will require additional protection conditions and procedures, when they are carried out on: a) People with disabilities highly dependent on care and attention. b) People with moderate or severe cognitive impairment. c) Serious psychiatric patients, whether or not they are hospitalized. d) People in health emergency situations. e) Critically ill patients with intensive care. f) Patients with terminal diseases. These investigations must meet at least the following conditions: 1) They may not be contrary to the best interests of the patient. 2) They will seek therapeutic benefit with a reasonable possibility of superiority over the standard treatment 3) They may not have a greater risk than the patient's own conditions and methods Treatment alternatives 4) The informed consent process will be implemented to the most reasonable way possible to meet their requirements, including the participation of family members and Authorized representative. 5) In cases where the patient is not the one who gives consent, he will be informed as soon as possible and you can withdraw from the investigation without any consequence for your due attention and care. 6) Any other that defines the regulation to this law. Article sheet ARTICLE 66.- Native migrant and collective communities particularly vulnerable Clinical research in vulnerable groups can only be carried out to the extent that accredit the following circumstances: a) That the investigation is carried out with the objective of treating and benefiting the community in some own and characteristic disease of this or another of high prevalence. b) That the researcher and the sponsor commit, reliably, to respect the value system, worldview and culture of the community that will participate in the study, and to adapt the study design and procedures to the customs of each community original. c) That the consent of each participant belonging to an original community be preceded by information provided in the original language of their culture, in case of that does not understand Spanish and that, in any of these cases, the researcher guarantees the understanding of the information and freedom of the decision made by him or the participant. d) That the investigation has the approval of a CEC that met with the presence of a community representative, elected by the same community, and with the authorization of the Conis. Article sheet ARTICLE 67.- Subordinate groups Research involving human beings, which are carried out on people or groups that are under the authority of researchers or that of a third party, or in certain dependency situations that may violate or affect their autonomy, and that do not involve a Direct bene fi t for research participants, they require special attention for the Application of this law. They should be considered subordinate groups by reason of authority, between others, students, residents and / or concurrent of medicine or other health sciences, people deprived of their liberty and police and security officials. These investigations can only be performed when the following conditions are met: a) The investigation is carried out with the purpose of achieving a benefit for the subordinate group under study. b) The investigation cannot be carried out in non-subordinate population groups. c) The investigation implies a minimum risk or burden for the people included in the study. Article sheet ARTICLE 68.- Clinical investigations with pregnant women or in period of lactation Pregnant or breastfeeding women should not participate in an investigation clinical, unless the following conditions are met simultaneously: a) That comparable results cannot be obtained in non-pregnant or in-period women breastfeeding b) That the research involves a minimum risk to their health, from the product of the conception at any stage of pregnancy or infant, or that the benefit exceeds the risk. c) That the objective of the investigation is to obtain new knowledge that results in bene fi t of other women or the product of conception at any stage of the Pregnancy or infant. Article sheet ARTICLE 69.- Clinical investigations with persons deprived of liberty Persons deprived of liberty should not be unreasonably denied the possibility of participate in clinical research or have access to medications, vaccines and other elements of research that may represent therapeutic or preventive benefit for them. Special attention should be given to guarantee the willingness of consent in this population, applying a suitably proven scientific methodology that guarantees reasonably that the consent of the private or the deprived of liberty is unquestionably voluntary. Article sheet CHAPTER X SANCTIONS ARTICLE 70.- Sanitary and administrative measures The Ministry of Health, the Conis or the CEC, as appropriate, should know and dictate the corresponding sanitary and administrative measures to avoid or amend those actions contrary to this law incurred by researchers, sponsors and any other interested party to intervene in a research project; all of the above without prejudice to civil liability, criminal or disciplinary that may correspond to the offender. Article sheet ARTICLE 71.- Precautionary measures During the processing of administrative procedures or investigations in judicial headquarters that question the legality of the activity of the researcher, the sponsor or the CEC, the ICO or the OAC and for the purpose of protecting the health and safety of the participants in an investigation, the competent body may impose the necessary precautionary measures. Investigations may be suspended temporarily or definitively, partially or totally, investigator or the approval of research projects in case the administrative authority or in judicial headquarters it is considered necessary. The competent body, through a well-founded resolution and prior hearing of the interested parties, must resolve whether it confirms, modifies or revokes the action taken. To do this, you must apply the procedure which establishes the Contentious-Administrative Procedural Code. Article sheet ARTICLE 72.- Infringements of the researcher or the sponsor, the ICO or the OAC The Conis, prior due process, may impose a fine of up to thirty percent (30%) of the total value of the investigation, in case the researcher or the sponsor, the ICO or the OAC incur in any of the following infractions: a) You have provided false information or omitted relevant information during the process of approval or execution of a research project. b) Start a research project without the proper approval of the CEC. c) Breaches or unreasonably delays compliance with the obligations set forth in this law. d) Any other breach of their obligations under the law. To determine the applicable sanction, the seriousness of the offense by the researcher, the sponsor, the ICO or the OAC or the employees, representatives or representatives of the company, and recidivism of the offenses against this law. The Conis will publish the list of researchers, the sponsors, the ICOs or the CAOs sanctioned, on the website of the Ministry of Health. Article sheet ARTICLE 73.- Infringements of the CEC The Conis may impose a fine on employees, representatives or representatives of a CEC up to three hundred times the base salary, in accordance with Law No. 7337, of May 5, 1993, and its reforms, a law that creates the concept of base salary for special crimes of the Criminal Code, in If any of them incur any of the following infractions: a) Breaches or unreasonably delays compliance with the obligations that this law grants, as well as any other obligation provided for in this law, in Law No. 5395, Law General de Salud, of October 30, 1973, in the code of morals or ethics of schools professionals to whom the researchers belong, or in the regulatory provisions of the aforementioned legal bodies, or any other applicable legal norm. b) Do not resolve or channel, in a timely manner, the complaints filed by the persons who They participate in the investigations, for damages suffered. c) Any other breach of their obligations under the law. To determine the applicable penalty, the seriousness of the offense, the degree of fault or the existence of fraud by employees, representatives or representatives of the CEC and its recidivism. Article sheet ARTICLE 74.- Coordination The Ministry of Health and Conis will determine the coordination mechanisms necessary for the most correct and efficient application of controls, special sanitary measures and sanctions provided for in this law. The proceeds of the fines set forth in this article will be distributed from the as follows: fifty percent (50%) to Conis and fifty percent (50%) to CEC, in if the breach sanctioned was from a sponsor or an investigator. In the case of the imposition of fines to the CEC, the product of these will correspond to the Conis. Article sheet ARTICLE 75.- Challenges Against the resolutions issued by the CEC, in the exercise of their powers, there will be recourse of appeal before the Conis. The appeal must be filed within five business days of the notification of the corresponding resolution. The resolution imposing a fine shall constitute an executive title against the offender. The Conis or the CEC, as appropriate, will be entitled to collect it. Article sheet ARTICLE 76.-Penalty procedure The sanctioning process will apply the procedure established in Law No. 6227, General Law of the Public Administration, of May 2, 1978. Article sheet ARTICLE 77.- Punishable facts If the breach of the obligations provided for in this law or its regulations result punishable, the Minister of Health, the Conis or the CEC, or who has knowledge of the punishable act, according to Correspond, communicate what is conducive to the Public Prosecutor to promote and exercise the relevant criminal actions. Article sheet ARTICLE 78.- Improper experimentation Who submits a person to research for the application of medicines, drugs, substances, treatments, techniques, devices or procedures, without duly informing you of the experimental condition of these and the risks it runs, and without express consent, written and documented of the victim or his legal representative and authorization of the procedure by part of a CEC; or who has used the victim's inability to issue a consent, duress, threat, deception, misinformation, manipulation or any other illicit means to obtain such consent, will be punished with imprisonment from three to eight years. Who promotes or conducts biomedical scientific research without having the Informed consent validly granted by the participants or their legal representative, except that the respective CEC has exempted from compliance with such requirement in accordance with this law, or has used coercion, threat, deception, misinformation, manipulation, or any other unlawful means to obtain such consent, a prison sentence of Three to eight years. Article sheet ARTICLE 79.- Severe undue experimentation The prison sentence will be five to ten years, when the behaviors described in the article above are carried out by public officials or are repeat investigators in the sanctioned conduct or when committed to the detriment of minors, women in a state of pregnancy, the elderly and people who are incapable or who for any reason cannot express their Opposition to the practice of research. Article sheet ARTICLE 80.- Disability In addition to the corresponding prison sentence, the judicial authority must establish the penalty of disqualification for a period of five to ten years for investigation processes biomedical or for the exercise of their profession, or both, according to the assessment of the facts, to the person that has committed the acts typified in the previous articles. Article sheet ARTICLE 81.- Influence trafficking with biomedical research Members of ethical committees will be sentenced to one to three years scientists (CEC) and officials of public or private institutions that authorize, facilitate or hire biomedical research in which they participate or have interests economic companies in which they, their spouses or partners, or their relatives by consanguinity or affinity until the third grade inclusive, be part of their boards of directors, Participate directly or by interposite natural or legal person in your share capital, or work as researchers Article sheet ARTICLE 82.- Gifts and coercion A prison sentence of three to five years will be imposed on the member of a scientific ethics committee that accepts any kind of gifts from people or companies that carry out research biomedical, without prejudice to other sanctions and responsibilities that proceed in accordance with the legal system. Article sheet ARTICLE 83.- Offering of gifts and coercion A person who offers gifts or exercises will be imposed three to five years in prison coercion to the members of a CEC to obtain favorable results in the authorization or any stage of the investigation, without prejudice to other sanctions and responsibilities arising from compliance with the legal system. Article sheet ARTICLE 84.- Improper use of privileged information Anyone using his position in the public service or in the private sector uses protocols or medical or social records of patients or users, to locate, recruit or contact participants for the biomedical research that meant economic benefit to him, his spouse or partner, or to his relatives by consanguinity or affinity until the second grade inclusive, will be sanctioned with prison sentence of one to three years, without prejudice to other penalties and responsibilities that may apply in accordance with the legal system. Article sheet CHAPTER XI FINAL PROVISIONS ARTICLE 85.- Violation of privacy The person who discloses or publishes will be punished with a penalty of two to four years in prison, by any means, private information about the participants in a clinical experiment, without the prior consent of these. Article sheet ARTICLE 86.- Regulation The Executive Power shall regulate this law within a period of six months; without However, the lack of regulation will not prevent its application. Article sheet ARTICLE 87.- Derogatory Articles 25, 26, 64, 65, 66, 67 and 68 all of Law No. 5395, General Law of Health, October 30, 1973. Article sheet TRANSITORY I.- CECs of public or private entities are authorized, which, in effect, are hereby law they are operating, to continue doing it and start the approval of clinical investigations in strict compliance with the provisions of this law. However, within six months counted from the constitution and installation of the Conis, such CEC are obliged to be accredited before the Conis adapting to the requirements demanded in the present law for its functioning. After this six month period expires, the CEC that have not requested the respective accreditation, they will automatically lose their authorization to operate. Article sheet TRANSITORY II.- The Ministry of Health is authorized to allocate human, fi nancial and financial resources. any other type, that are required for the operation of the Conis until it has not the funds necessary to operate and fully comply with the functions assigned to it in this law Within the period of six months from the effective date of this law, the Ministry of Health will formulate the corresponding budget that contemplates the content for the allocation of places required for the formation, strengthening and operation of the competencies of the Conis, as well as the provision of resources to finance infrastructure and equipment required for the efficient and efficient operation of said body. The Ministry of Health will send to Ministry of Finance the corresponding plan of expenses, to be included in favor of the Conis in the next extraordinary budget a transfer for the total amount that results from the allocation of those resources. Article sheet TRANSITORY III.- Within forty-five days following the integration and entry into operation of the Conis, this body will present for approval, to the Comptroller General of the Republic, First operating budget. Likewise, it is authorized to include in this first budget the items that allow retroactively pay the diets to the members of the Conis for the sessions at would have attended and been held since its installation and until the date of approval by the Comptroller General of the Republic of that budget. This authorization also applies to pay, retroactively, administrative expenses incurred during that same period. Article sheet TRANSITORY IV.- If at the end of sixty business days, counted from the publication of this law or, in its case, as of the expiration date of the appointment in the Conis of the institutions obliged to do it, which they would not have done, automatically the members that have not been appointed will be represented by: a) The Minister of Health. b) The Minister of Science and Technology. c) The president of the Costa Rican Social Security Fund. d) The president of Conare. e) The president of the Costa Rican Bar Association. f) A prosecutor of any of the professional associations of Physicians and Surgeons, Pharmacy, Dentists or Microbiology Surgeons, at the option of the Ministry of Health, and by a community representative who will appoint the head of the Ministry of Health. g) A citizen representative, who will appoint the head of the Ministry of Health. The members appointed in this way will be in their positions until the respective holder and his substitute in the manner provided in this law or the respective regulation. The Conis members, mentioned in the previous paragraph, are obliged to inform and accredit in the First session attended by the name of their respective alternate, who must meet the requirements established in this law. Article sheet TRANSITORY V.- As long as the Conis does not have its own internal audit, it may be audited by the audit. Internal Ministry of Health, in accordance with Law No. 8292, General Internal Control Law, of July 31, 2002 and Law No. 7428, Organic Law of the Comptroller General of the Republic, of 7 September 1994. It applies from its publication. Given in the Presidency of the Republic, San José, on the twenty-second day of the month of April of the year two thousand and fourteen. Article sheet Generation date: 02/17/2020 09:04:07 p.m. Go to the beginning of the document